56 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0

FDA Recall
Terminated ·Philips Electronics North America Corporation·Product code MHX·January 3, 2018

Philips Healthcare IntelliVue Info Center iX, A.0 866023

FDA Recall
Terminated ·Philips Electronics North America Corporation·Product code MHX·November 25, 2015

Radiomat Lightweight Cassettes

FDA Recall
Terminated ·AGFA Corp.·Product code IXA·January 26, 2005

Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

FDA Recall
Open, Classified ·Philips North America·Product code DSI·April 19, 2023

Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

FDA Recall
Completed ·Philips North America Llc·Product code LNH·August 11, 2021

Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262

FDA Recall
Completed ·Philips North America Llc·Product code LNH·August 11, 2021

Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·September 10, 2010

Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

FDA Recall
Terminated ·Iba Dosimetry·Product code IYE·April 26, 2017

iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

FDA Recall
Terminated ·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·August 20, 2013

COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological

FDA Recall
Terminated ·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·September 25, 2014

IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2

FDA Recall
Terminated ·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·December 10, 2015

COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

FDA Recall
Terminated ·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·February 2, 2015

myQA iON; Article Number: MQ10-000;

FDA Recall
Open, Classified ·IBA Dosimetry GmbH Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·April 1, 2025

Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm

FDA Recall
Open, Classified ·Securitas Healthcare LLC·Product code IQA·September 25, 2023

Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm

FDA Recall
Open, Classified ·Securitas Healthcare LLC·Product code IQA·September 25, 2023

MediBeads Neck Wrap, Item Number 34320

FDA Recall
Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

FDA Recall
Terminated ·Intel-GE Care Innovations LLC·Product code IQA·July 30, 2011

Thermalon Eye Compress, Item Number 2434

FDA Recall
Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3

FDA Recall
Open, Classified ·Securitas Healthcare LLC·Product code IQA·December 8, 2025

Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3

FDA Recall
Open, Classified ·Securitas Healthcare LLC·Product code IQA·December 8, 2025